BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LINE SET FOR AQUARIUS

    MDR report key: 1891587 · Received November 5, 2010

    Report

    Report Number
    1423500-2010-05300
    Event Type
    Malfunction
    Date Received
    November 5, 2010
    Date of Event
    October 12, 2010
    Report Date
    October 13, 2010
    Manufacturer
    HAEMOTRONICS SPA
    Product Code
    FKJ
    PMA / PMN Number
    K063293
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE SAMPLE WAS REQUESTED. A FOLLOW UP REPORT WILL BE SUBMITTED WHEN THE EVALUATION RESULTS BECOME AVAILABLE.

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION: THE ACTUAL SAMPLE WAS RECEIVED AND EVALUATED BY (B)(4). THE SUPPLIER CONFIRMED THAT THERE WAS PARTICULATE ON THE SPIKE. HOWEVER, THEY COULD NOT IDENTIFY THE NATURE OF THE PARTICLES WITH THEIR VISUAL ANALYSIS AND THEREFORE SENT IT TO ANOTHER LAB TO TRY TO IDENTIFY THE PARTICLES. THE OUTSIDE LAB WAS ALSO UNABLE TO IDENTIFY THE PARTICLE, AND THEREFORE ROOT CAUSE COULD NOT BE DETERMINED. A BATCH REVIEW WAS CONDUCTED AND NO ISSUES WERE FOUND RELATED TO THE REPORTED CONDITION DURING THE MANUFACTURE OF THE LOT. SIMILAR REPORTS HAVE BEEN RECEIVED BY BAXTER FOR THE REPORTED PROBLEM. BAXTER WILL CONTINUE TO MONITOR SIMILAR REPORTS TO DETERMINE IF FURTHER ACTIONS ARE REQUIRED.

    Description of Event or Problem · 1

    IT WAS NOTED SOME YELLOW P.M.ON THE Y-CONNECTOR BEFORE THE PATIENT USE. NO PATIENT INJURY OR MEDICAL INTERVENTION WAS REPORTED ALONG WITH THIS COMPLAINT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LINE SET FOR AQUARIUS FILTER, BLOOD, DIALYSIS FKJ HAEMOTRONICS SPA B102358

    Patients

    Seq Age Sex Outcome Treatment
    1